Method and apparatus for manufacturing a capsule

ABSTRACT

A method of manufacturing a capsule  12  for holding a substance  14  includes providing a capsule body  2  having a closed end  5  and an opposed open end  6 ; providing a diaphragm  4  having a closed end  7  and an opposed open end  8 ; partially filling the body  2  with substance  14 ; providing a gas-tight chamber; providing a nitrogen gas environment within the chamber; applying a partial vacuum to the chamber; supporting an outer side  43  of the body  2 ; supporting an inner side  102  of the diaphragm  4 ; while supporting the body  2  and the diaphragm  4 , inserting the closed end  7  of the diaphragm  4  into the open end  6  of the body  2  until regions of the body  2  and the diaphragm  4  overlap one another, thereby closing off the open end  6  of the body  2  and forming a chamber  104  within which the substance  14  is held; and heat welding the overlapping regions of the capsule body  2  and the diaphragm  4  to one another to hermetically seal the chamber  104.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/IB2012/055372 filed Oct. 5, 2012 and claims the benefit of SouthAfrican Application No. 2011/07330 filed Oct. 6, 2011, the disclosuresof which are incorporated herein by reference in their entirety

FIELD OF INVENTION

This invention relates to a method and apparatus for manufacturing acapsule for holding a substance. In this specification the term“non-toxic gas” must be interpreted to mean any gas which is non-toxicto a human or animal body when ingested and which specifically does notcontain oxygen.

SUMMARY OF INVENTION

According to a first aspect of the invention there is provided a methodof manufacturing a capsule for holding a substance, the method includingthe steps of:

providing a first capsule portion of flexible material for holding thesubstance, the first capsule portion having a closed end and an opposedopen end;

providing a second capsule portion of flexible material having a closedend and an opposed open end;

at least partially filling the first capsule portion with the substance;

supporting at least part of an outer side of the first capsule portion;

supporting at least part of an inner side of the second capsule portion;and

while supporting an outer side of the first capsule portion and an innerside of the second capsule portion, inserting the closed end of thesecond capsule portion into the open end of the first capsule portionuntil regions of the capsule portions overlap one another, therebyclosing off the open end of the first capsule portion and forming achamber within which the substance is held.

The first capsule portion may comprise a hollow cylindrical tubular bodywhich defines the open end and the closed end, the closed end beingdome-shape.

The second capsule portion may comprise a hollow cylindrical tubularbody which defines the open end and the closed end, the closed end beingdome-shape.

The second capsule portion may have a predetermined length dimensiondefined between the ends of the second capsule portion, which is shorterthan a length dimension defined between the ends of the first capsuleportion, the method including inserting the second capsule portion intothe first capsule portion to a depth wherein the second capsule portionis wholly located within the first capsule portion.

The method may include supporting inner and outer sides of theoverlapping regions of the first capsule portion and the second capsuleportion.

The method may include bonding the overlapping regions of the firstcapsule portion and the second capsule portion to one another, therebyto hermetically seal the chamber.

The method may include bonding the first capsule portion to the secondcapsule portion while supporting said overlapping regions of the firstand second capsule portions.

The method may including bonding the overlapping regions of the firstcapsule portion and the second capsule portion to one another byapplying heat and pressure to the first and second capsule portions soas to fuse the overlapping regions of the capsule portions to oneanother.

The method may include providing a gas-tight chamber in order to achievea controlled gaseous environment with the chamber, the method includinglocating first and second capsule portions within the chamber andinserting the closed end of the second capsule portion into the open endof the first capsule portion while in the chamber.

The method may include providing a non-toxic gas environment within thechamber and inserting the closed end of the second capsule portionwithin the first capsule portion while the capsule portions are locatedwithin the non-toxic gas environment.

The method may include applying a partial vacuum to the chamber therebyto reduce gas pressure within the chamber to a sub-atmospheric pressurewhen inserting the closed end of the second capsule portion into theopen end of the first capsule portion.

The method may include the steps of providing a cap; at least partiallyfilling the second capsule portion with an additional substance; andsecuring the cap to one of the first capsule portion and the secondcapsule portion so as to define an additional chamber within which theadditional substance is held.

The method may include securing the cap to one of the first capsuleportion and the second capsule portion in an arrangement wherein the capcloses the open end of the second capsule portion.

The first capsule portion and the second capsule portion may both beformed of digestible material rendering the capsule digestible.

The first capsule portion, the second capsule portion and the cap mayall be formed of digestible material, rendering the capsule digestible.

According to a second aspect of the invention there is provided anapparatus for manufacturing a capsule for holding a substance, theapparatus including:

first capsule supporting means including at least one first capsulesupporting structure which is dimensioned and configured for supportingat least part of an outer side of a first capsule portion of flexiblematerial for holding the substance therein, the first capsule portionhaving a closed end and an opposed open end;capsule filling means including one or more nozzles for dispensing thesubstance, the capsule filling means being operable for at leastpartially filling the first capsule portion which is supported, in use,by the first capsule supporting structure;second capsule supporting means including at least one second capsulesupporting structure which is configured and dimensioned for supportingat least part of an inner side of a second capsule portion of flexiblematerial having a closed end and an opposed open end, the second capsulesupporting means being displaceable between:

-   -   a first condition wherein the second capsule supporting        structure of the second capsule supporting means is spaced apart        from the first capsule supporting structures of the first        capsule supporting means; and    -   a second condition wherein the second capsule supporting        structure is operable to insert a closed end of the second        capsule portion supported thereon within the first capsule        portion supported by the first capsule supporting structure,        until a region of the second capsule portion overlaps a region        of the first capsule portion, thereby closing off the open end        of the first capsule portion so as to form an assembled capsule        defining a chamber within which the substance is held.

The first capsule supporting structure may be configured and dimensionedto receive a first capsule portion therein in a snug sliding fit.

The first capsule supporting structure may be in the form of a hollowreceptacle formation which is shaped and dimensioned so as to correspondto a shape and dimensions of an outer side of the first capsule portion.

The second capsule supporting structure may be configured anddimensioned to be inserted into the second capsule portion in a snugsliding fit.

The second capsule supporting structure may be in the form of a mandrelformation which is shaped and dimensioned so as to correspond to a shapeand dimensions of an inner side of the second capsule portion.

The apparatus may include capsule bonding means for bonding theoverlapping regions of the first capsule portion and the second capsuleportion of each assembled capsule to one another, thereby tohermetically seal the chamber. The capsule bonding means may be in theform of at least one capsule bonding element for applying heat andpressure to overlapping regions of the assembled capsules for bondingthe overlapping regions to one another.

The apparatus may include a gas-tight chamber within which the first andsecond capsule portions are located when inserting the first capsuleportion into the second capsule portion when forming an assembledcapsule, thereby to achieve a controlled gaseous environment within thechamber.

The apparatus may include a vacuum device for applying a partial vacuumto the chamber for reducing gas pressure within the chamber tosub-atmospheric pressures.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features of the invention are described hereinafter by way of anon-limiting example of the invention, with reference to and asillustrated in the accompanying diagrammatic drawings. In the drawings:

FIG. 1 shows a sectional side view of a capsule produced in accordancewith the method of manufacturing a capsule, in accordance with the firstaspect of the invention;

FIG. 2 shows a sectional side view of another embodiment of a capsuleproduced in accordance with the method of manufacturing a capsule, inaccordance with the first aspect of the invention;

FIG. 3 shows a fragmentary perspective view of an apparatus formanufacturing a capsule, in accordance with a second aspect of theinvention;

FIG. 4 shows a perspective view of a capsule support tray of theapparatus of FIG. 3;

FIG. 5 shows a fragmentary sectional side view of a capsule fillingassembly of the apparatus of FIG. 3;

FIG. 6 shows a fragmentary sectional side view of a vacuum chamberassembly and a diaphragm inserting assembly of the apparatus of FIG. 3,both illustrated in raised positions;

FIG. 7 shows a fragmentary sectional side view of the vacuum chamberassembly and the diaphragm inserting assembly of FIG. 6, bothillustrated in lowered positions;

FIG. 8 shows a fragmentary sectional side view of the vacuum chamberassembly and diaphragm inserting assembly of FIG. 6, with the vacuumchamber assembly illustrated in the lowered position and the diaphragminserting assembly illustrated in the raised position;

FIG. 9 shows a fragmentary sectional side view of a capsule bondingassembly of the apparatus of FIG. 3, illustrated in a raised position;and

FIG. 10 shows a fragmentary, sectional side view of the capsule bondingassembly of FIG. 9, illustrated in a lowered position.

DETAILED DESCRIPTION OF THE DRAWINGS

With reference to FIGS. 1 and 3 to 10 of the drawings, an apparatus inaccordance with a second aspect of the invention is designated generallyby the reference numeral 10. The apparatus 10 is configured formanufacturing a capsule 12 in accordance with the method formanufacturing a capsule, in accordance with a first aspect of theinvention.

The capsule 12 is in the form of a digestible hard gelatine capsule forholding a substance such as, for example Omega-3 oil 14 which, whencontained in a capsule, is required to be held in hermetic isolation fortwo main reasons. Firstly, because Omega-3 oil 14 is in a flowableliquid state and, as such, must be held in a liquid-tight chamber withinthe capsule. Secondly, because Omega-3 oil 14 is susceptible todegradation by oxidation when exposed to oxygen present in theatmosphere. The capsule 12 comprises, broadly, a first capsule portionin the form of a capsule body 2 and a second capsule portion in the formof a diaphragm 4. The capsule body 2 is of a flexible gelatinousmaterial and is in the form of hollow cylindrical tubular body whichdefines a closed end 5 and an opposed open end 6. The diaphragm 4 is ofa flexible gelatinous material having a hollow cylindrical tubular bodywhich defines a closed end 7 and an opposed open end 8.

As is illustrated in FIG. 3 of the drawings, the apparatus 10 includes,broadly, first capsule supporting means in the form of a number ofcapsule support trays 16; a capsule filling assembly 20; a vacuumchamber assembly 22; second capsule supporting means in the form of adiaphragm inserting assembly 24; and capsule bonding means in the formof a capsule bonding assembly 28.

With reference to FIGS. 3 and 4 of the drawings, each capsule supporttray 16 comprises an aluminium plate 30 having forty two hollowreceptacles 32 defined therein; a peripheral rubber seal 34; and fortytwo internal passages 36 which extend through the aluminium plate 30from bottom end regions 38 of the aluminium plate 30 to a lowermost partof a different one of the receptacles 32, the purpose of which will beexplained in more detail hereinbelow. The receptacles 32 are spaced anequal distance apart from one another and are arranged in a gridarrangement comprising six rows by seven columns. Each receptacle 32 isconfigured and dimensioned for supporting an outer side 43 of a capsulebody 2. More specifically, each receptacle 32 is shaped and dimensionedso as to correspond to the shape and dimensions of the outer side 43 ofthe capsule body 2, such that the capsule body 2 is received within thereceptacle 32 in a snug sliding fit. More specifically, as illustratedin FIGS. 5 to 10 of the drawings, a capsule body 2 is located withineach receptacle 32 in an arrangement wherein the receptacle 32 supportsthe outer side 43 of the capsule body 2.

Each capsule support tray 16 is displaced, in use, to various positionson the apparatus which correspond to various operational stations of theapparatus 10. More specifically, each capsule support tray 16, isdisplaced, in use, sequentially between: a capsule filing station,wherein the capsule support tray 16 is disposed beneath the capsulefilling assembly 20; a vacuum-insertion station, wherein the capsulesupport tray 16 is disposed beneath the vacuum chamber assembly 22 andbeneath the diaphragm inserting assembly 24; and a capsule bondingstation, wherein the capsule support tray 16 is disposed beneath thecapsule bonding assembly 28.

As is illustrated in FIGS. 3 and 5 of the drawings, the capsule fillingassembly 20 includes a movable capsule filling head 49 and a metereddispenser 53. The capsule filling head 49 includes seven nozzles 52which are spaced an equal distance apart from one another and which arealigned in a row, so that the position of each nozzle 52 correspondswith a particular receptacle 32 of the aluminium plate 30 locatedbeneath it, as shown in FIG. 5 of the drawings. The rows of nozzles 52are sequentially moved to positions wherein the nozzles 52 arepositioned above each row of the receptacles 32 of the aluminium plate30. The metered dispenser 53 is operable to deliver a specific metereddose of Omega-3 oil 14 to each nozzle 52, for partially filling eachcapsule body 2 which is supported within the receptacles 32 of thecapsule support tray 16.

With reference to FIGS. 3 and 6 to 8 of the drawings, the vacuum chamberassembly 22 comprises a vacuum chamber housing 54; a vacuum chamberdisplacing assembly 55 for displacing the vacuum chamber housing 54; avacuum port 58 and a nitrogen delivery port 60. The vacuum chamberhousing 54 has a sealing formation 64 defined on a lower peripheraledge; and a handle formation 62 extending from the housing 54, thepurpose of which will be described in more detail hereinbelow. Thevacuum chamber displacing assembly 55 comprises a winch (not shown)having a steel cable 84 with a hook 86 at a free end of the steel cable84 connected to the handle formation 62 of the housing 54. The vacuumchamber displacing assembly 55 is operable to displace the housing 54between a raised position, as shown in FIGS. 3 and 6 of the drawings anda lowered position, as shown in FIGS. 7 and 8 of the drawings, whereinthe sealing formation 64 of the housing 54 sealingly engages the rubberseal 34 of the capsule support tray 16, so as to define an internalvacuum chamber 56 which is defined between the housing 54 and thecapsule support tray 16. The vacuum port 58 is connected to a vacuumpump (not shown) so as to form a partial vacuum within the vacuumchamber 56 when the vacuum pump is operated. The nitrogen delivery port60 is connected to a source of nitrogen gas for delivering nitrogen gasto the vacuum chamber 56.

With reference to FIGS. 3 and 6 to 8 of the drawings, the diaphragminserting assembly 24 is mounted within the housing 54 of the vacuumchamber assembly 22 and includes forty two diaphragm inserting rods 90and a hydraulically-operated rod-displacing arrangement 85 fordisplacing the diaphragm inserting rods 90. Each diaphragm inserting rod90 has a threaded end (not shown), an opposite end which is connected toa mandrel 88 and a hollow internal passage 91 extending from thethreaded end of the rod 90 to the opposite end thereof. Each mandrel 88has a hollow central passage 89 defined therethrough and is configuredfor supporting a diaphragm 4. More specifically, each mandrel 88 isconfigured and dimensioned to be inserted through an open end 8 of adiaphragm 4 so as to be received within the diaphragm 4 in a snugsliding fit. More specifically, each mandrel 88 is dimensioned so as tocorrespond to a shape and dimension of an inner side 102 of a diaphragm4. The rod displacing arrangement 85 comprises four guide posts 107, acarrier plate 103; forty two springs 105 and nuts 92; an actuator plate106 and hydraulic actuator 108; and a movable piston 101. The guideposts 107 are mounted at upper ends thereof to the housing 54 of thevacuum chamber assembly 22. The carrier plate 103 is slidably receivedon the guide posts 107 and has 42 equi-spaced apertures which extendtherethrough, through which the diaphragm inserting rods 90 arereceived. Each spring 105 is received on a different one of thediaphragm inserting rods 90 and the nuts 92 are threaded onto thethreaded ends of the diaphragm inserting rods 90, as illustrated inFIGS. 6 to 8 of the drawings. The hydraulic actuator 108 is operable todisplace the piston 101 for displacing the carrier plate 103 and thediaphragm inserting rods 90 mounted thereto, for reasons which will beexplained in more detail hereinbelow.

In use, the vacuum chamber displacing assembly 55 displaces the housing54 into its lowered position, as shown in FIGS. 7 and 8 of the drawings,wherein the sealing formation 64 of the housing 54 sealingly engages therubber seal 34 of the capsule support tray 16. The vacuum pump isactivated so as to draw air out of the vacuum chamber 56 so as to form apartial vacuum within the vacuum chamber 56 so as to reduce internalpressure within the vacuum chamber 56 to a pressure of between 10 kPa to70 kPa. Nitrogen gas is then introduced into the vacuum chamber 56 viathe nitrogen delivery port 60 to increase the internal pressure withinthe vacuum chamber 56 to a pressure of 20 kPa to 90 kPa, whichparticularly is below atmospheric pressure for reasons which will beexplained in more detail hereinbelow.

In use, the rod displacing arrangement 85 is operable to displace thepiston 101 for displacing the inserting rods 90 and the mandrels 88between a first condition, as shown in FIG. 6 of the drawings, whereinthe mandrels 88 are spaced apart from the receptacles 32 of the capsulesupport trays 16 and a second condition, shown in FIG. 7 of thedrawings, wherein the mandrels 88 are operable to insert a closed end 7of each diaphragm 4 supported thereon, within a different one of thecapsule bodies 2, supported by the receptacles 32 of the capsule supporttrays 16, until a region of each diaphragm 4 overlaps a region of adifferent one of the capsule bodies 2, thereby closing off the open ends6 of the capsule body 2 thereby to form an assembled capsule 12 defininga chamber 104 in which the Omega-3 oil 14 is held.

It will be appreciated that the receptacles 32 and the mandrels 88together support inner and outer sides of overlapping region of thecapsule body 2 and the diaphragm 4, as shown in FIG. 7 of the drawings,during insertion of the closed end 7 of the diaphragm 4 into the openend 6 of the capsule body 2. The provision of support for an outer sideof the capsule body 2 and an inner side of the diaphragm 4 isadvantageous during insertion, as this ensures that the open ends 6, 8of the capsule body 2 and the diaphragm 4 do not distort and/or changeshape when the closed end 7 of the diaphragm 4 is inserted within thecapsule body 2. It will be understood in this regard that gelatinecapsules are particularly fragile and easily distort and/or rupture whenrelatively small forces are applied thereto. Any distortion to the shapeof the capsule body 2 will also hamper removal of the capsule body 2from the receptacle 32. Furthermore, the applicant has also found thatthe provision of support for the diaphragm 4 and an outer side of thecapsule body 2 permits smooth displacement of the diaphragm 4 relativeto the capsule body 2 when inserting the closed end 7 of the diaphragm 4into the open end 6 of the capsule body 2.

With reference to FIGS. 3, 9 and 10 of the drawings, the capsule bondingassembly 28 comprises a capsule bonding head 118, a support structure120 for supporting the capsule bonding head 118 and a hydraulic heatingmandrel actuator 122. The capsule bonding head 118 has forty two heatingmandrels 124 mounted to lower ends of rods 126 which project from alower end of the bonding head 118, as shown in FIGS. 9 and 10 of thedrawings. The heating mandrels 124 are spaced a predetermined distanceapart from one another. More specifically, the spacing between theheating mandrels 124 corresponds with the spacing between thereceptacles 32 of the aluminium plate 30 of the capsule support trays16. More specifically, as illustrated in FIGS. 9 and 10 of the drawings,each heating mandrel 124 is located above a different one of thereceptacles 32 of the capsule support tray 16. The hydraulic heatingmandrel actuator 122 is operable to displace the heating mandrels 124between a raised position as shown in FIG. 9 of the drawings, whereineach heating mandrel 124 is spaced away from the capsule support tray116 and a lowered position, wherein each heating mandrel 124 is insertedinto an open end 7 of a diaphragm 4, as illustrated in FIG. 10 of thedrawings.

In use, each heating mandrel 124 is heated to a temperature of between100° C. to 120° C. (optimally 110° C.) and applied to the diaphragm 4for a period of approximately five to ten seconds, as illustrated inFIG. 10 of the drawings. In use, the heating mandrel 124 supports, formsand heat welds overlapping parts of the capsule body 2 and the diaphragm4 to one another, so as to form a fused overlapping wall region 109, asshown in FIG. 10 of the drawings. The fused overlapping wall region 109comprises between 0.8 mm and 1.5 mm of overlapping parts of the capsulebody 2 and the diaphragm 4 which are heat welded to one another.

It will be appreciated that inner and outer sides of the capsule body 2and the diaphragm 4 are supported by the receptacles 32 and the heatingmandrels 124 during bonding of the overlapping parts of the diaphragm 4and the capsule body 2, as illustrated in FIG. 10 of the drawings. Morespecifically, as can be seen from FIG. 10 of the drawings, the heatingmandrels 124 and the receptacles 32 together support inner and outersides of overlapping parts of the capsule body 2 and the diaphragm 4,when the capsule body 2 and the diaphragm 4 are heat welded to oneanother. The applicant believes that the supporting of the inner andouter sides of the capsule body 2 and the diaphragm 4 during bonding thecapsule body 2 and the diaphragm 4 to one another is also advantageousto ensure proper and optimal alignment and orientation of the capsulebody 2 and the diaphragm 4 relative to one another. The applicant hasfound that the supporting, as described hereinabove, ensures that thecapsule 12 is properly formed and hermetically sealed. Furthermore, theapplicant envisages that supporting the capsule body 12 and thediaphragm 4 during bonding limits the possibility of distortion and/orcollapse of the capsule body 2 and the diaphragm 4 during bonding.

It will also be understood that, in use, the nitrogen gas providedwithin the chamber 104 reduces concentrations of atmospheric oxygenwithin the chamber 104 and thereby reduces the rate of oxidation of theOmega-3 oil 14. Furthermore, by providing a sub-atmospheric gas pressurewithin the chamber 104, the possibility of the Omega-3 oil 14 seepingout of the chamber 104 is significantly reduced. In addition, theapplicant has found that reducing the gas pressure within the chamber104 to a pressure below atmospheric pressure, is particularlyadvantageous during bonding of the overlapping regions of the diaphragmand the capsule body to one another. In this regard, the applicant hasfound that during bonding, the mandrel 124 also heats up the Omega-3 oil14 in the chamber 104, causing it to expand. As a result of thisexpansion, the pressure within the chamber 104 increases. To overcomethis problem, the internal pressure within the chamber 104 is reduced toa pressure which is sufficiently below atmospheric pressure, such that,when heat and pressure are applied during bonding, the internal pressurewithin the chamber 104 remains below atmospheric pressure particularlyafter the expansion of the Omega-3 oil 14 due to heating of thediaphragm and capsule body. This ensures that the internal pressurewithin the chamber 104 is at or below atmospheric pressure afterbonding, so as to ensure that the chamber 104 is not pressurised to apressure above atmospheric pressure, so as to ensure an effectivehermetic seal. This reduction of the pressure within the chamber 104, isthus beneficial as increased internal pressure within the chamber 104 isundesirable as it may compromise the sealing of the chamber 104.Furthermore, the applicant has found that reducing gas pressure withinthe chamber 104 to a pressure below atmospheric pressure, is alsoadvantageous after bonding. More specifically, the applicant has foundthat users of the capsule 12 often store the capsules 12 in relativelyhot environments such as, for example, in their cars where ambienttemperatures are increased. The applicant has found that reducing gaspressure within the chamber 104 when manufacturing the capsule, to apressure below atmospheric pressure specifically enables the capsules tobe used in relatively hot environments which may increase pressurewithin the chamber 104. This ensures that the capsule body 2 and thediaphragm 4 are not pressurized by internal pressure within the chamber104 to pressures above ambient pressure when ambient temperatures towhich the capsules 12 are exposed rise to relatively high levels. Inthis regard, it will be appreciated that it is likely that the hermeticseal will be compromised if internal pressure within the chamber 104exceeds atmospheric pressure and remains at this higher pressure for anextended period of time.

The apparatus 10 further includes a support tray vacuum system (notshown) and an inserting rod vacuum system (not shown). The support trayvacuum system is operable to produce a partial vacuum within theinternal passage 36 of the capsule support tray 16, so as to produce asuction in the lower end of the receptacles 32 for holding the capsulebodies 2 in position within the receptacles 32 when withdrawing themandrels 88 and the heating mandrels 124 from the diaphragms 4, in use.The inserting rod vacuum system is operable to produce a partial vacuumwithin the internal passage 91 of the diaphragm inserting rods 90 andthe internal passage 89 of the mandrels 88, so as to produce a suctionat a lower end of each mandrel 88 for holding the diaphragms 4 inposition on each mandrel 88, in use.

The applicant envisages that the capsule 12 may be used in particularapplications wherein a capsule is required to hold an additionalsubstance such as, for example, a medicament 130, which is required tobe held apart from the Omega-3 oil 14 contained within the chamber 104.More specifically, the diaphragm 4 of the capsule 12 is filled with themedicament 130 and the capsule 12 is capped, as illustrated in FIG. 3 ofthe drawings, using a conventional capsule capping and filling machinewhich is used to cap known conventional capsule bodies with knownconventional caps 132, so as to form a capsule 134 as shown in FIG. 2 ofthe drawings, each capsule 134 having an additional chamber 136 withinwhich the medicament 130 is contained. Alternatively, the applicantenvisages that in certain circumstances, the capsules 12 and the caps132 will be supplied to a customer of the applicant, thereby permittingthe applicant's customer to fill and cap the capsule 12, with a desiredsubstance contained in the additional chamber 136, using the customersown conventional capsule capping and filling machine.

It will also be appreciated that it is extremely important that theshape and/or dimensions of the open ends 6, 8 of the capsule body 2 andthe diaphragm 4 are maintained when the capsule body 2 and the diaphragm4 are bonded to one another, particularly so as to permit the cap 132 tofit snugly, as shown in FIG. 2 of the drawings. Furthermore, the mannerin which the capsule body 2 and the diaphragm 4 is supported, asdescribed hereinabove, is extremely important to ensure that the shapeand dimensions of the capsule 12 are maintained so as to permit thecapsule 12 to be fed through conventional capsule capping and fillingmachines, which, due to their high speed and precision of operation, canonly process capsules having precise and uniform shapes and dimensions.

The applicant envisages that the digestible capsule 134 is advantageousfor containing two substances, such as, the Omega-3 oil 14 and themedicament 130, which particularly must be held in separate chambersapart from one another. As such, other substances other than the Omega-3oil 14 and the medicament 130 may be held in the chamber 104 and theadditional chamber 136. The applicant furthermore envisages that thecapsule 134 is particularly suitable for holding a wet and a drycomposition, wherein the wet composition is in a liquid state, and, assuch, is required to be held in a hermetic sealed chamber so as toprevent the liquid from leaking out of the hermetically sealed chamber.The applicant envisages that the capsule 134 is furthermore advantageousfor holding two compositions which must be separated from one another soas to prevent degradation and/or reaction and/or contamination of one orboth of the compositions. In particular, the applicant envisages thatthe capsule 134 is advantageous for holding a pharmacologicalcomposition in one of the chambers 104,136 and a natural composition inthe other one of the chambers 104,136.

It will be appreciated that the exact configuration of the apparatus 10used in accordance with the method of the invention, may vary greatlywhilst still incorporating the essential features of the method of theinvention as described hereinabove. Further the apparatus 10 mayimplement a method other than the method in accordance with theinvention and similarly the method in accordance with the invention maybe implemented on an apparatus other than the apparatus 10 describedhereinabove.

The applicant envisages that the capsule body 2, the diaphragm 4 and thecap 132 are formed in accordance with known manufacturing procedures forforming hard gelatine capsules.

The applicant also envisages that the apparatus 10 and the method inaccordance with the invention may be used to manufacture other types ofcapsules other than the digestible capsules 12 and 134 describedhereinabove. More specifically, the applicant envisages that a capsule(not shown) may be produced by the method and/or by the apparatus whichis configured for containing two part compositions which are required tobe separated from one another, such as, for example, highly reactive orexplosive substances, or, alternatively, two part adhesives.

In another embodiment of the invention (not shown), the apparatusincludes a combined diaphragm inserting and capsule bonding assemblywhich replaces the diaphragm inserting assembly 24 and the capsulebonding assembly 28. The combined diaphragm inserting and capsulebonding assembly (not shown) is located with the vacuum chamber 56. Assuch, both the insertion of the diaphragm 4 into the capsule body 2, ashereinabove described, and the bonding of the capsule body 2 and thediaphragm 4 to one another, as hereinabove described, occurs within thecontrolled gaseous environment of the vacuum chamber 56.

The invention claimed is:
 1. A method of manufacturing a capsule forholding a substance, comprising: providing a first capsule portion offlexible material for holding the substance, the first capsule portionhaving a closed end and an opposed open end; providing a second capsuleportion of flexible material having a closed end and an opposed openend; at least partially filling the first capsule portion with thesubstance; supporting at least part of an outer side of the firstcapsule portion and supporting at least part of an inner side of thesecond capsule portion, at overlapping regions of the capsule portions;and while supporting the outer side of the first capsule portion and theinner side of the second capsule portion, inserting the closed end ofthe second capsule portion into the open end of the first capsuleportion until regions of the capsule portions overlap one another,thereby closing off the open end of the first capsule portion andforming a chamber within which the substance is held.
 2. The method asclaimed in claim 1, wherein the first capsule portion comprises acylindrical body which defines the open end and the closed end, theclosed end being dome-shape.
 3. The method as claimed in claim 1,wherein the second capsule portion comprises a cylindrical body whichdefines the open end and the closed end, the closed end beingdome-shape.
 4. The method as claimed in claim 1, wherein the secondcapsule portion has a predetermined length defined between the ends ofthe second capsule portion, which is shorter than a length definedbetween the ends of the first capsule portion, the method furtherincluding inserting the second capsule portion into the first capsuleportion to a depth wherein the second capsule portion is wholly locatedwithin the first capsule portion.
 5. The method as claimed in claim 1,further including bonding the overlapping regions of the first capsuleportion and the second capsule portion to one another, thereby tohermetically seal the chamber.
 6. The method as claimed in claim 5,wherein the first capsule portion is bonded to the second capsuleportion while supporting said overlapping regions of the first andsecond capsule portions.
 7. The method as claimed in claim 5, whereinthe overlapping regions of the first capsule portion and the secondcapsule portion are bonded to one another by applying heat and pressureto the first and second capsule portions thereby to fuse the overlappingregions of the capsule portions to one another.
 8. The method as claimedin claim 1, wherein prior to inserting the closed end of the secondcapsule portion into the open end of the first capsule portion, themethod further includes: providing a gas-tight chamber to achieve acontrolled gaseous environment with the chamber; locating the first andsecond capsule portions within the chamber; and inserting the closed endof the second capsule portion into the open end of the first capsuleportion while in the chamber.
 9. The method as claimed in claim 8,further including: providing a non-toxic gas environment within thechamber: and inserting the closed end of the second capsule portionwithin the first capsule portion while the capsule portions are locatedwithin the non-toxic gas environment.
 10. The method as claimed in claim8, wherein a partial vacuum is applied to the chamber thereby to reducegas pressure within the chamber to a sub-atmospheric pressure wheninserting the closed end of the second capsule portion into the open endof the first capsule portion.
 11. The method as claimed in claim 1,further including: providing a cap; at least partially filling thesecond capsule portion with an additional substance; and securing thecap to one of the first capsule portion and the second capsule portionthereby to define an additional chamber within which the additionalsubstance is held.
 12. The method as claimed in claim 11, furtherincluding securing the cap to one of the first capsule portion and thesecond capsule portion whereby the cap closes the open end of the secondcapsule portion.
 13. The method as claimed in claim 1, wherein the firstcapsule portion and the second capsule portion are both formed ofdigestible material.
 14. The method as claimed in claim 11, wherein thefirst capsule portion, the second capsule portion and the cap are formedof digestible material.